TheranosticTrials.org

Clinical Trial · NCT05197257

68Ga-PSMA-11 PET in Patients With Prostate Cancer

Overview

Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

Sponsor

University of Colorado, Denver

Phase

Phase 3

Contacts

Bennett Chin (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05197257

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy): a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of \>0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA
  • Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines
  • Histopathologically proven prostate adenocarcinoma

Exclusion

  • Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging.
  • Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.
  • Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.